| Primary Device ID | 20801741044063 |
| NIH Device Record Key | 71cc45e6-0638-462b-958e-d2c44bd699ad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARISTA |
| Version Model Number | AM0004 |
| Catalog Number | AM0004 |
| Company DUNS | 001191048 |
| Company Name | Davol Inc. |
| Device Count | 2 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741044069 [Unit of Use] |
| GS1 | 10801741044066 [Primary] |
| GS1 | 20801741044063 [Package] Contains: 10801741044066 Package: CA [5 Units] In Commercial Distribution |
| LMG | Agent, absorbable hemostatic, non-collagen based |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2024-10-22 |
| Device Publish Date | 2014-09-12 |
| 00801741233678 - GalaFLEX | 2025-10-03 GalaFLEX Scaffold, 2.5 cm x 7.6 cm, Rectangle |
| 00801741233685 - GalaFLEX | 2025-10-03 GalaFlex Scaffold, 5.0 cm x 15.0 cm, Rectangle |
| 00801741233692 - GalaFLEX | 2025-10-03 GalaFlex Scaffold, 5.0 cm x 20.0 cm, Rectangle |
| 00801741233708 - GalaFLEX | 2025-10-03 GalaFlex Scaffold, 10.0 cm x 20.0 cm, Rectangle |
| 00801741233715 - GalaFLEX | 2025-10-03 GalaFlex Scaffold, 15.0 cm x 20.0 cm, Rectangle |
| 00801741233722 - GalaFLEX LITE | 2025-10-03 GalaFlex LITE Scaffold, 2.5 cm x 7.6 cm, Rectangle |
| 00801741233739 - GalaFLEX LITE | 2025-10-03 GalaFlex LITE Scaffold, 5.0 cm x 15.0 cm, Rectangle |
| 00801741233746 - GalaFLEX LITE | 2025-10-03 GalaFlex LITE Scaffold, 5.0 cm x 20.0 cm, Rectangle |